32 BioPharm International Quality and Regulatory Sourcebook eBook March 2022 www.biopharminternational.com
to manage expirations, recalls, and ver-
ified returns.
However, no amount of data will
be of any use if it is not pure, trusted,
accurate, and complete to begin with.
Accurate product and location identi-
fiers, properly formatted according to
industry standards, are essential. Many
organizations are currently running old
or proprietary systems and identifica-
tion schemes, and many others could
be using outdated or incorrect data.
Trading partners need data they
can trust, knowing it is accurate, com-
plete, and always up to date. Multiple
data sources must have consistent
core information, which also must be
s y n c h r o n i z e d f o r c o l l a b o r a t i o n
between organizations.
That's why full adoption of data-
standards is an absolute necessit y.
When adopted across industry, GS1
Standa rds prov ide a common lan-
guage and one source of truth that
trading partners can reference and
understand interchangeably.
Creating and maintaining trusted
data is an ongoing process that never
ends. Without trusted data, traceabil-
ity falls apart. Master data must be
scrupulously scrubbed and curated;
trusted product data must be recog-
nized as a vital asset, and ongoing data
management a fundamental priority.
TIME IS SHORT
The manufacturers did not reach 90%
barcoding success overnight. It took
top-down organizational and industry
commitment, involving a considerable
investment of time and resources. Each
year, each barcode assessment revealed
glitches and errors that needed fixing
so the barcodes would scan properly.
Syntax and printing issues had to be
worked out. Lessons learned informed
the suppliers' practices for improve-
ments, based on these evaluations.
Establishing interoperability is even
more complicated. Organizations gen-
erally manage data differently, often
using proprietary systems that are not
designed to communicate with external
entities in an interoperable manner.
Incompatible data formats or unin-
tended business processes can prevent
effective exchange. Deep collaboration
is needed to ensure compatibility.
It will take time, and a period of
trial and error is part of the process.
Ma nu fac t u rers shou ld a l ready be
working with distributors, so these
distributors can work with their down-
stream partners, on testing information
exchange. The deadline is perilously
near if we consider the remaining out-
standing tasks to be completed.
KEEPING PATIENTS SAFE
When all pharmaceutical supply chain
stakeholders are sharing trusted, stan-
dardized data in real time, full trace-
ability will be enabled and the DSCSA
mission fulf illed, ultimately helping
protect patients' "five rights" of med-
ication use: assuring that the right
patient can receive the right drug, at
the right time, in the right dose, and
via the right route.
REFERENCES
1. GS1 US, "Progress on 2023
DSCSA Interoperability," gs1us.
org, accessed Feb. 16, 2022.
2. FDA, Enhanced Drug
Distribution Security at the Package
Level Under the Drug Supply
Chain Security Act Guidance for
Industry, Draft Guidance (CDER,
CBER, June 2021).
BP
Quality and Regulatory Sourcebook Regulations: Supply Chain
The deadline is
perilously near
if we consider
the remaining
outstanding tasks to
be completed.
In this episode of our sister publication's—Pharmacuti-
cal Technology—Drug Solutions Podcast, Chris Spivey,
Editorial Director, talks about the economic and geopo-
litical benefits of controlling pharmaceutical manufac-
turing through reshoring with Dr. Fernando Muzzio, dis-
tinguished professor of chemical and biochemical engi-
neering, Rutgers University, and Frederic Kahn, VP Sales,
Wavelength Pharmaceuticals.
Supply chain fragility and geopolitical instability is dis-
cussed as background to in-shoring pharmaceutical man-
ufacturing by Dr. Fernando Muzzio, distinguished pro-
fessor of chemical and biochemical engineering, Rutgers
University and Frederic Kahn, VP Sales, Wavelength Phar-
maceuticals. This discussion covers reforming regulations
and economics, while introducing novel flow chemistries,
robotics, digitalization, and a heightened agility for invest-
ment in education, national strategy, and communications.
CLICK HERE TO LISTEN TO THIS PODCAST.
About Drug Solutions
Pharmaceutical Technology presents the Drug Solutions
podcast, where the editors will chat with industry experts
who will share insights into your biggest questions—from
the technologies, to strategies, to regulations related to
the development and manufacture of drug products.
—The Editors of BioPharm International
Drug Solutions Podcast: Securing Manufacturing Independence Through Re-shoring Facilities to USA
